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U.S. Department of Health and Human Services

For Consumers

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Tentative approval or generic stavudine

The Food and Drug Administration (FDA), on July 1, 2005, announced the tentative approval of stavudine capsules manufactured by Aurobindo Pharma LTD., Hyderabad, India. This formulation of stavudine is the first generic version of the approved drug, Zerit, manufactured by Bristol-Myers Squibb to receive tentative approval. Tentative approval allows the product to be considered for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR).

Stavudine is in the class of drugs called Nucleoside Reverse Transcripts Inhibitors (NRTIs) which helps keep the AIDS virus from reproducing. This antiretroviral drug is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The agency’s tentative approval means that although existing patents and/or exclusivity prevent marketing of these products in the U.S., they meet all of FDA’s quality, safety and efficacy standards.

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration